About the Role

We are looking for a Quality Engineer to join a Medical Device manufacturing company in North Wales. This is an excellent opportunity for a quality professional who is passionate about compliance, continuous improvement, and delivering products that make a meaningful difference to patients' lives.

As a Quality Engineer, you will play a key role in ensuring our products and processes meet the highest quality and regulatory standards. You will work closely with manufacturing, engineering, R&D, and global quality teams to support quality management activities, investigations, risk management, and process improvement initiatives.

What You'll Be Doing

• Supporting and improving the site's Quality Management System (QMS)
• Developing, reviewing, and maintaining quality procedures, work instructions, and records
• Participating in internal and external quality audits
• Supporting product and process quality activities throughout the product lifecycle
• Contributing to design reviews, verification, validation, and design transfer activities
• Supporting process validation activities (IQ/OQ/PQ)
• Conducting risk assessments and maintaining risk management documentation in line with ISO 14971
• Investigating product and process non-conformities
• Leading root cause investigations and supporting CAPA activities
• Helping ensure compliance with applicable medical device regulations and quality standards
• Analysing quality data, trends, and performance metrics
• Leading or supporting continuous improvement projects using Lean Six Sigma methodologies
• Collaborating with cross-functional stakeholders to drive quality and operational excellence

About You

To be successful in this role, you will ideally have:

• A degree (or equivalent experience) in Engineering, Science, or a related discipline
• At least 2 years' experience in a Quality Engineering, Quality Assurance, or similar role
• Experience working within a regulated manufacturing environment
• Knowledge of Quality Management Systems (QMS)
• Understanding of CAPA and non-conformance processes
• Experience using data analysis tools such as Excel (Minitab experience is advantageous)
• Strong problem-solving and root cause analysis skills
• Excellent communication and stakeholder management abilities
• Ability to work effectively across multidisciplinary teams
• Knowledge of change control and validation processes would be beneficial
• Experience with FMEA or other risk management tools would be advantageous
• Six Sigma Green Belt qualification, or experience applying quality engineering tools and techniques, would be desirable

Why Join Us?

• Be part of a global organisation that develops products which improve patient outcomes and quality of life
• Work within a collaborative and supportive quality team
• Gain exposure to medical device quality systems and regulatory requirements
• Opportunity to lead improvement projects and shape manufacturing quality performance
• Competitive salary and benefits package
• Career development and progression opportunities